Angiotensin Receptor Blockers and Angiotensin-converting Enzyme Inhibitors and Adverse Outcomes in Patients With COVID19 (BRACE-CORONA)

D'Or Institute for Research and Education

Status: Unknown

Conditions: COVID-19; Corona Virus Infection

Treatments: Other: Suspension or Maintenance of Angiotensin Receptor Blockers and Angiotensin-converting Enzyme Inhibitors

Study type: Interventional

Funder types: Other

Identifiers

NCT04364893

PRJ_2003

Details and patient eligibility

About

Suspension of Angiotensin Receptor Blockers and Angiotensin-converting Enzyme Inhibitors and Adverse Outcomes in Hospitalized Patients With Coronavirus Infection.

Full description

Several interactions by pre-existing therapies for chronic diseases, therapies used by SARS-CoV2 infection generate doubts about risks and benefits. Among these situations in which the current data indicate a situation of equipoise would be about the maintenance or suspension of ACEI / BRA in patients with SARS-CoV2 infection. Increasing the expression of ECA-2 could increase the binding to the virus, however, there are studies that indicate this increase in ECA-2 could be protective. So far, there is no clinical evidence to confirm any of the theories, and this question can only be clarified through a randomized clinical trial.

The objective is to evaluate the impact of the suspension of the use of angiotensin-converting enzyme (ACE) inhibitors and angiotensin receptor blockers (BRA) on the length of hospital stay and on the mortality of patients with SARS-CoV2 infection.

Enrollment: 700 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients hospitalized with COVID-19 diagnosis using ACE inhibitors or blockers of angiotensin receptor;
• Patients ≥ 18 years old;
• Maximum use of 3 antihypertensive drugs;
• Sign the consent form.

Exclusion criteria

• Severe evolution with orotracheal intubation, use of mechanical ventilation and / or hemodynamic instability in the first 24 hours until COVID-19 diagnosis confirmation;
• Patients hospitalized per decompensated congestive heart failure in the last 12 months;
• Use of Sacubitril/Valsartan
• Pregnancy
• Recent acute renal failure and shock

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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700 participants in 2 patient groups

Group 1

Other group

Description:

Maintenance of Angiotensin Receptor Blockers and Angiotensin-converting Enzyme Inhibitors

Treatment:

Other: Suspension or Maintenance of Angiotensin Receptor Blockers and Angiotensin-converting Enzyme Inhibitors

Group 2

Other group

Description:

Suspension of Angiotensin Receptor Blockers and Angiotensin-converting Enzyme Inhibitors

Treatment:

Other: Suspension or Maintenance of Angiotensin Receptor Blockers and Angiotensin-converting Enzyme Inhibitors